Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients

Kidney Transplantation Clinical Trial

— OPTIMUM  

Official title:

Organ Function Preservation by the Combination Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients: OPTIMUM Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159080
• Other study ID #: CERL080AKR07T
• Secondary ID: CERL080AKR07T
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2010
• Last updated: March 12, 2017
• Start date: April 1, 2010
• Est. completion date: November 30, 2016

Study information

• Verified date: March 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with mycophenolate sodium dose increment will preserve renal allograft function without rising adverse effects

Primary endpoints:

1. estimated GFR (MDRD equation) 12 months after randomization

2. estimated GFR change from randomization to end of the study (calculated by MDRD equation and Nankivell equation)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: November 30, 2016
• Est. primary completion date: October 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

<Inclusion criteria>

1. The patients between the ages of 20 and 75 years who received kidney transplantation one to five years prior to the study.

2. Taking tacrolimus and corticosteroid, with or without additional purine synthesis inhibitor within the recent 3 months

3. Patients with serum creatinine (sCr) level = 2.0 mg/dL and variation of sCr < 30% for recent 3 months

4. Patients with urine proteinuria/creatinine ratio (PCR) = 1 g/g, or 24 hour urine protein = 1g/day for recent 3 months

5. Patients who provided informed consent.

<Exclusion criteria>

1. Patients who received combined non-renal transplantation, multiple kidney transplantation or re-transplantation

2. Patients whose graft from non-heart beating cadaveric donor

3. graft from HLA-identical living related donor

4. ABO blood group incompatible donor or HLA desensitized recipients

5. Patients with hypersensitivity history to mycophenolate sodium, mycophenolate acid, or mycophenolate mofetil, or to any other excipients

6. Patients with hypoxanthin e-guanine phosphoribosyl-transferase such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome

7. Patients with history of disease which could affect absorption of study medication (e.g. diabetic gastropathy, previous gastrectomy)

8. Patients with positive serologic test results, in recipient or donor, for human immunodeficiency virus, hepatitis B or C virus

9. Patients with liver function test abnormality (alanine aminotransferase, aspartate aminotransferase, or total bilirubin > 3 times from upper normal limit), neutropenia (absolute neutrophil count < 1,500/uL or white blood cell count < 2,500/uL), or thrombocytopenia (platelet < 75,000)

10. Patients with history of cancer within 5 years, except for successfully treated localized non-melanocytic skin cancer

11. Patients who were either pregnant, lactating, planning to become pregnant in the next 12 months

12. Patients who taken medicine from other trial within 30 days.

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• routine dose tacrolimus and less myfortic
oral regular dose of tacrolimus + less dose of myfortic trough level of tacrolimus will be 5-10 ng/mL and oral myfortic dose will be 180-360 mg twice a day
• reduced dose tacrolimus and conventional myfortic
low dose of tacrolimus + maximum dose of myfortic target trough level of tacrolimus should be reduced to 2-5 ng/mL for 3 months after randomization and oral MPS dose increased to 540-720mg twice a day

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Asan Medical Center

Sponsors (3)

Lead Sponsor	Collaborator
Asan Medical Center	Samsung Medical Center, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimated GFR (MDRD equation)12 months after randomization		12 months after randomization
Secondary	Urine protein excretion	24hr urine collection or urine protein/creatinine ratio	12 months after randomization
Secondary	graft survival	12 month graft survival	12 month after randomization
Secondary	follow-up loss	frequency of follow-up loss	From randomization to 12 months after randomization
Secondary	Allograft biopsy	number of performed allograft biopsy performed	From randomization to 12 months after randomization
Secondary	Treated or biopsy proven acute rejection		From randomization to 12 months after randomization
Secondary	estimated GFR change from randomization to end of the study	calculated by MDRD equation and Nankivell equation	12 months after randomization